FDA Grants Tabrecta Regular Approval for Metastatic NSCLC

The FDA granted capmatinib (Tabrecta, Novartis) regular approval for adults with metastatic non-small cell lung cancer with mutations leading to mesenchymal-epithelial transition (MET) exon 14 skipping.

 

Capmatinib previously received accelerated approval, which was contingent upon further study results, for this indication in May 2020. The FDA’s decision to grant regular approval was based on new data from the GEOMETRY mono-1 trial, which included an additional 63 patients and 22